FDA 510(k) Application Details - K233827

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K233827
Device Name	Oximeter
Applicant	OxiWear, Inc. 1111 Arlington Blvd #305 Arlington, VA 22209 US Other 510(k) Applications for this Company
Contact	Shavini Fernando Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2023
Decision Date	08/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review